The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zoll Pd-1400 Pacer/defibrillator.
| Device ID | K911956 |
| 510k Number | K911956 |
| Device Name: | ZOLL PD-1400 PACER/DEFIBRILLATOR |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Albert T Kelley |
| Correspondent | Albert T Kelley ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-02 |
| Decision Date | 1991-07-31 |